Director, Manufacturing Operations — Medical Devices

Freudenberg Sealing Technologies S.a.s. di Externa Italia S.r.l.u.; Carpinteria (CA); On-site; USD 120,000 - 150,000; Full time

Job summary

Freudenberg Group in Carpinteria, CA leads manufacturing operations across the site to meet safety, quality, delivery, cost and continuous improvement targets. You will oversee planning, performance management, and development of an Operations team across multiple shifts.

Collaborate with Product Development, Quality, Regulatory and Finance to ensure readiness and alignment with business objectives; drive lean initiatives, ensure compliance with ISO 13485, FDA, EU MDR, and manage budgets and

Qualifications

• Bachelor's degree or higher in Engineering, Operations, or Business.
• 10+ years of manufacturing operations experience, including at least 5 years in a senior leadership role.
• Deep knowledge of global regulatory requirements (FDA, ISO 13485, EU MDR, CFDA).
• Proven success leading multi-shift teams in a regulated production environment.
• Strong budgeting, CAPEX management, and financial acumen.

Responsibilities

• Lead all manufacturing operations for the site, including production, scheduling, and support functions to meet safety, quality, delivery, cost, and continuous improvement targets.
• Oversee department-level planning, goal setting, and performance management across multiple shifts or production units.
• Direct and develop an Operations team to ensure strong leadership pipeline and succession planning.
• Collaborate with SBU functional leaders of Product Development, Quality, Regulatory and Finance to ensure operational readiness and alignment with business objectives.
• Drive operational excellence through lean manufacturing, process improvement initiatives, and employee engagement programs.
• Ensure compliance with global regulatory and quality standards, including ISO 13485, FDA, EU MDR, and other applicable country-specific requirements.
• Lead operational input into site-level budget planning, cost management, and capital investments.
• Monitor and report on operational KPIs and recommend actions to improve output, quality, efficiency, and customer satisfaction.

Skills

Lean manufacturing

Regulatory knowledge

Budget management

Cross-functional leadership

Stakeholder management

Education

Bachelor's degree in Engineering, Operations, or Business

Tools

SAP

Microsoft Office

Job description

Freudenberg Group in Carpinteria, CA leads manufacturing operations across the site to meet safety, quality, delivery, cost and continuous improvement targets. You will oversee planning, performance management, and development of an Operations team across multiple shifts.

Collaborate with Product Development, Quality, Regulatory and Finance to ensure readiness and alignment with business objectives; drive lean initiatives, ensure compliance with ISO 13485, FDA, EU MDR, and manage budgets and